MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW; PTA BALLOON DILATATION CATHETER

Catalog Number 436-2012X

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was received.The investigation is on-going.

Event Description

It was reported that there was difficulty advancing the device to the lesion and then difficulty removing the device and intervention was required.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve and there was n difficulty removing the balloon sleeve.There were no kinks noted on the device prior to use.The patient had left long segment occlusion of the superficial femoral artery.There were no stents present within the treatment site or tracking path.A retrograde approach was made.The guidewire was advanced to the left femoral popliteal and could not be returned to the true lumen.A cook4f micro sheath was then used with a v18 guidewire along with the complaint device to strengthen support.After the device was inserted into the sheath there was difficulty and the device could not be removed.Therefore the surgeon cut the balloon delivery rod but the device could still not be removed.The sheath and device and guidewire were then withdrawn together.It was reported that the device did not separate or break at any time during the procedure.The device was inserted into the patient once and was never inflated.There were no kinks noted on the device during or after use and force was required when using the device.Another savvy long device was used and the same failure occurred but this device was not cut.Another device was used to complete the procedure at that time.The patient did not experience any complications as a result of the failure with the device however the operation was prolonged.There was no patient injury reported.

Manufacturer Narrative

It was reported that there was difficulty advancing the device to the lesion and then difficulty removing the device and intervention was required.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve and there was n difficulty removing the balloon sleeve.There were no kinks noted on the device prior to use.The patient had left long segment occlusion of the superficial femoral artery.There were no stents present within the treatment site or tracking path.A retrograde approach was made.The guidewire was advanced to the left femoral popliteal and could not be returned to the true lumen.A cook4f micro sheath was then used with a v18 guidewire along with the complaint device to strengthen support.After the device was inserted into the sheath there was difficulty advancing the device.The device was attempted to be removed then however there was difficulty and the device could not be removed.Reportedly the surgeon did not want to withdraw the sheath and guidewire with the device as this would prolong the procedure so the surgeon cut the balloon delivery rod in an attempt to remove the device but the device could still not be removed.The sheath and device and guidewire were then withdrawn together.It was reported that the device did not separate or break at any time during the procedure apart from when the device was cut into two pieces.The device was inserted into the patient once and was never inflated.There were no kinks noted on the device during or after use and force was required when using the device.Another savvy long device was used and the same failure occurred but this device was not cut.Another device was used to complete the procedure at that time.The patient did not experience any complications as a result of the failure with the device however the operation was prolonged.There was no patient injury reported.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.This is the first reported complaint for this lot number and issue to date.The device was returned for evaluation.Two devices were returned together for evaluation (two separate complaints).The 2 devices were returned wrapped around each other, bloody and in a poor state.The method of packing of the devices may have been a factor as there were no anomalies noted during the prep of the device.The device was returned in 3 separate sections.The first section consisted of the hub and the device length was 470mm.The guidewire was still inserted within the hub and had exited at the first break point.The inner and outer were badly bunched.The hub was printed as expected and there were no visual defects observed.On the second section the guidewire was exposed for a length of 190mm from the first section.A 20mm badly bunched section of the device was a fixed to the guidewire.The third section was separate to the first and second.It consisted of the outer, balloon and tip sections.Its length was 1060mm.The outer cut point was uneven.No packing returned.The device arrived back without a sleeve.Bunching was noted on the balloon at the distal markerband.There was also bunching noted in the middle of the balloon.Dried red substance was noted inside the balloon.A partial (40%) radial tear was noted on the balloon.No visual defects were observed on the distal tip.No functional examination was carried out on the device as it was not applicable to the complaint.The result of the investigation is confirmed.However the event information describes that user handling methods contributed to the reported event.It was described that there were no anomalies to the device prior to use or during preparation.The device did not separate or break at any time during the procedure apart from when the device was cut into two pieces when the surgeon cut the balloon delivery rod in an attempt to remove the device.Patient factors were also a likely contributory factor as there was a long segment occlusion of the superficial femoral artery.Based on analysis performed no additional action is required at this time.The ifu states: device description the savvy® long percutaneous transluminal angioplasty (pta) peripheral catheter family are a non-reusable coaxial design catheter with a semi-compliant balloon mounted on its distal tip.¿ the hub/¿y¿ connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon.Indication for use the savvy® long catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries.These catheters are not designed to be used in the coronary arteries.Directions for use.Inspection and preparation note: a 0.018¿ (0.457 mm) guidewire must be inserted in the savvy® long catheter across the balloon during any inflation of the balloon.¿ remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve while holding the catheter as close to the balloon as possible.¿ if any resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, the product should not be used.¿ the catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.¿ prepare a mixture of contrast medium and normal saline as per normal procedure.(recommended 25%/75%) gently withdraw the catheter.As the balloon exits the vessel, use a smooth, gentle, steady, counterclockwise motion.If resistance is felt upon removal then the balloon and the sheath should be removed together as a unit under fluoroscopic guidance, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.¿ apply pressure to the insertion site according to standard practice or hospital protocol for percutaneous vascular procedures.Warning: after use this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and with applicable local, state and federal laws and regulations.(b)(4).

Event Description

It was reported that there was difficulty advancing the device to the lesion and then difficulty removing the device and intervention was required.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve and there was n difficulty removing the balloon sleeve.There were no kinks noted on the device prior to use.The patient had left long segment occlusion of the superficial femoral artery.There were no stents present within the treatment site or tracking path.A retrograde approach was made.The guidewire was advanced to the left femoral popliteal and could not be returned to the true lumen.A cook4f micro sheath was then used with a v18 guidewire along with the complaint device to strengthen support.After the device was inserted into the sheath there was difficulty advancing the device.The device was attempted to be removed then however there was difficulty and the device could not be removed.Reportedly the surgeon did not want to withdraw the sheath and guidewire wit the device as this would prolong the procedure so the surgeon cut the balloon delivery rod in an attempt to remove the device but the device could still not be removed.The sheath and device and guidewire were then withdrawn together.It was reported that the device did not separate or break at any time during the procedure apart from when the device was cut into two pieces.The device was inserted into the patient once and was never inflated.There were no kinks noted on the device during or after use and force was required when using the device.Another savvy long device was used and the same failure occurred but this device was not cut.Another device was used to complete the procedure at that time.The patient did not experience any complications as a result of the failure with the device however the operation was prolonged.There was no patient injury reported.

• Brand Name: SAVVY LONG OTW
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: fiona nimhullain ; 539237111
• MDR Report Key: 6900346
• MDR Text Key: 87619764
• Report Number: 9616666-2017-00094
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 436-2012X
• Device Lot Number: 50142784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/04/2017
• Supplement Dates FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70