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

Catalog Number 436-2522X

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2017

Event Type  malfunction  

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.It was reported that there was no balloon sleeve on the device.The packaging was opened and it was noted that the balloon sleeve was missing.It was confirmed that the sleeve was not left in the packaging or did not fall on the floor.There was no patient involvement.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 event reported for this lot number and issue to date.The device was returned for evaluation.The device arrived back separated at the proximal bond.The total length of the returned device was approx.155.0mm, it should have been 150.0mm in length.No external or internal packing was returned.The sleeve was not returned.The hub was printed as expected and no visual defects were observed.There was a kink noted on the outer just at the proximal bond.The outer was separated at the proximal bond of the balloon.The inner was squeezed/flattened at the proximal markerband.The inner was stretched by approx.45mm in length.There was bunching noted on the balloon located in three area's in the middle of the balloon.The proximal bond was separated from the outer.No functional examination was carried out on the device as it was not applicable to the complaint.The evaluation of the complaint is inconclusive for the component missing failure mode reported.Based upon the available information a definitive root cause cannot be determined.The evidence around the break in the device at the proximal bond implies that handling techniques may have been a contributory factor during sleeve removal.This suggests that the sleeve had been originally fitted to the device.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 no balloon sleeve on the device.The packaging was opened and it was noted that the balloon sleeve was missing.It was confirmed that the sleeve was not left in the packaging or did not fall on the floor.There was no patient involvement.

• 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: 6669130
• MDR Text Key: 78577290
• Report Number: 9616666-2017-00037
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 436-2522X
• Device Lot Number: 50137839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• 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