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

Model Number	436-2522X
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
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 was confirmed for the material deformation failure mode reported.During evaluation a kink was noted on the inner catheter of the device at the exit of the strain relief.A detachment of the balloon and the outer catheter was noted and the inner catheter was also stretched in the detached area.There were no bends or twists noted on the device.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.It is unknown whether handling or procedural techniques contributed to the reported event.The definitive root cause for the reported packaging issue could not be determined based upon available information.Labeling review: the ifu for the savvy long product was reviewed and contains the following information relevant to the reported event: description: a 0.018¿ (0.457 mm) guidewire is recommended for use with the savvy® long catheter.Warnings: do not advance the guidewire, balloon dilation catheter, or any component if resistance is met, without first determining the cause and taking remedial action.Precautions: carefully inspect the catheter prior to use to verify that the catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.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.Expiry date: aug / 2019;.
Event or Problem Description
It was reported that the pta balloon catheter was allegedly difficult to remove from the sleeve.Reportedly, upon removal of the pta balloon catheter from the balloon sleeve, kinks and/or bends were allegedly identified on the balloon catheter shaft, 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: 8016603
• Report Number: 9616666-2018-00151
• Device Sequence Number: 11078250
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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 Model Number: 436-2522X
• Device Catalogue Number: 436-2522X
• Device Lot Number: 50142823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1