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

Model Number	436-2515X
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The result of the investigation is confirmed for the packaging issue reported.The sleeve was tight on the balloon and proved some difficultly to remove it during the evaluation.The evaluation also confirmed a detachment.The balloon was detached from the outer catheter at the proximal bond.The detachment may have been the effect of the unsuccessful removal of the sleeve during device preparation.The id of the sleeve was measured and found within specification.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.A review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.Expiry date: (b)(6) 2019.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 balloon guard on the pta balloon catheter allegedly was difficult to remove.Reportedly, another balloon catheter was used to complete the procedure.There was no reported patient injury.

• 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: 8026684
• Report Number: 9616666-2018-00155
• Device Sequence Number: 1756198
• 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
• Report Date (Section B): 10/31/2018

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: 436-2515X
• Device Catalogue Number: 436-2515X
• Device Lot Number: CMBN0146
• 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: 10/04/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1