MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA DILATION CATHETER

Model Number	436-2515X
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 05/2020).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.
Event or Problem Description
It was reported that during an angioplasty procedure for a total occlusion stenosis treatment the pta balloon allegedly ruptured during the first inflation under nominal pressure, and allegedly leaked contrast.Reportedly, the pta dilatation catheter was removed from the patient without incident, and another pta balloon catheter was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure for a total occlusion stenosis treatment the pta balloon allegedly ruptured during the first inflation under nominal pressure, and allegedly leaked contrast.Reportedly, the pta dilatation catheter was removed from the patient without incident, and another pta balloon catheter was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the investigation of the returned device confirmed the reported material rupture failure mode.A longitudinal rupture measuring 75mm in length was noted in the balloon.A kink was also observed on the inner and the outer catheter of the device 655mm from the strain relief.Based on the available information a definitive root cause has not been determined.It is unknown if patient factors, handling or procedural techniques may have contributed to the reported event.Labeling review: the ifu for the savvy long product was reviewed and contains the following information relevant to the reported event: (a) 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.(expiry date 05/2020).(eval code & desc - results 1 & conclusion 1).
Event or Problem Description
It was reported that during an angioplasty procedure for a total occlusion stenosis treatment the pta balloon allegedly ruptured during the first inflation under nominal pressure, and allegedly leaked contrast.Reportedly, the pta dilatation catheter was removed from the patient without incident, and another pta balloon catheter was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: this supplemental mdr is being submitted to report this event is no longer reportable based on new information received.H10: manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the investigation of the returned device confirmed the reported material rupture failure mode.A longitudinal rupture measuring 75mm in length was noted in the balloon.A kink was also observed on the inner and the outer catheter of the device 655mm from the strain relief.Based on the available information a definitive root cause has not been determined.It is unknown if patient factors, handling or procedural techniques may have contributed to the reported event.Labeling review: the ifu for the savvy long product was reviewed and contains the following information relevant to the reported event: (a) 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.(b) 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.(c) 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.H10: d4 (expiry date 05/2020), g4.H11: h3, h6 (eval code & desc - results 1 & conclusion 1).H11:section a through f - the information provided by bd 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 bd.

• Brand Name: SAVVY LONG OTW PTA DILATION CATHETER
• Common Device Name: PTA DILATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 7814918
• Report Number: 9616666-2018-00117
• Device Sequence Number: 19284871
• Product Code: LIT
• UDI-Device Identifier: 00801741132827
• UDI-Public: (01)00801741132827
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 436-2515X
• Device Catalogue Number: 436-2515X
• Device Lot Number: CMBT0363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 11/02/2020
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 08/31/2018; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1