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

Model Number	436-2522X
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
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 return of the device is pending.The investigation is currently underway.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 the pta balloon allegedly ruptured under burst rated pressure.Reportedly, another balloon was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that the pta balloon allegedly ruptured under burst rated pressure.Reportedly, another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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.Investigation summary: the result of the investigation was inconclusive for the failure mode - material rupture.The sleeve was still present on the balloon and due to the flattened area at the proximal bond and the two deep impressions it could not be removed.It is unknown how the failure mode was established.The evaluation did observe a break at the proximal bond.The device exhibited evidence that point to the user applying excessive force during device preparation when removing the sleeve / mandrel resulting in the break in the device.Thus handling or procedural techniques may have contributed to the break.However, based on the available information a definitive root cause has not been determined.Labeling review: 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.H10: g4, h6 (eval code & desc - method 5: 38 - visual inspection) h11: d10, h2, h3, h6 (eval code & desc - method 3), (eval code & desc - conclusion1), (eval code & desc - conclusion2).
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.Investigation summary: the investigation was inconclusive.The sample was not returned for evaluation.Based upon the available information a definitive root cause cannot be determined.It was unknown whether patient factors, handling or procedural techniques contributed to the reported event.Labeling review: (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.
Event or Problem Description
It was reported that the pta balloon allegedly ruptured under burst rated pressure.Reportedly, another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: SAVVY LONG OTW PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7294739
• Report Number: 9616666-2018-00022
• Device Sequence Number: 16446925
• Product Code: LIT
• UDI-Device Identifier: 00801741132889
• UDI-Public: (01)00801741132889
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2018

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 Expiration Date: 09/30/2019
• Device Model Number: 436-2522X
• Device Catalogue Number: 436-2522X
• Device Lot Number: 50143936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/06/2018; 05/21/2018
• Initial Report FDA Received Date: 02/24/2018
• Supplement Report FDA Received Date: 03/27/2018; 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1