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

Model Number	436-2515X
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number of 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 upon removal of the pta balloon catheter from the packaging, it was alleged that the balloon was detached from the catheter shaft prior to use, rendering the device unusable.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the production history for the device was reviewed and no anomalies were identified.The lot met all test release criteria.Nothing was found to indicate a manufacturing related cause for this event.This is the first reported complaint for this lot number and this issue to date.Investigation summary: the result of the investigation is confirmed for the failure mode reported.The balloon was detached from the outer catheter at the proximal bond.A longitudinal rupture was also observed on the balloon 11.5mm from the distal markerband.The device exhibited evidence (deep impressions noted 13mm and 105mm from the distal end of the sleeve) that point to the user applying excessive force, most likely during the device preparation when removing the sleeve / mandrel which resulted in the balloon detachment.Based upon the available information a definitive root cause cannot be determined.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.
Event or Problem Description
It was reported that upon removal of the pta balloon catheter from the packaging, it was alleged that the balloon was detached from the catheter shaft prior to use, rendering the device unusable.There was no patient contact.

• Brand Name: SAVVY LONG OTW PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7589830
• Report Number: 9616666-2018-00074
• Device Sequence Number: 2194805
• 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
• Report Date (Section B): 09/04/2018

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: 02/29/2020
• Device Model Number: 436-2515X
• Device Catalogue Number: 436-2515X
• Device Lot Number: CMBQ0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1