MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK OTW PTA DILATATION CATHETER

Model Number	426-1508X
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
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.(expiry date 12/2019).
Event or Problem Description
It was reported that the pta balloon catheter allegedly ruptured.It was further reported that the pta balloon was torn.There was no reported patient injury.
Event or Problem Description
It was reported that the pta balloon catheter allegedly ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
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 has confirmed the failure mode reported, material rupture.A longitudinal rupture was observed in the balloon beginning at the proximal bond and measuring 28mm in length.There was also a kink noted on the inner and outer at the exit of the strain relief.It is unlikely however that the kink is manufacturing related, as a 100% visual inspection for catheter kinks is performed.A guide wire check is also performed on 100% of devices during catheter production.The definitive root cause for the reported balloon rupture issue could not be determined based upon available information the manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.Finally it is unknown whether patient factors, handling or procedural techniques contributed to the reported event.Labeling review: balloon characteristics ¿ please check the package label for the rated burst pressure (rbp).It is important that the balloon not be inflated beyond the rated burst pressure.Pressures in excess of rated burst pressure may cause the balloon to burst.Compliance charts are provided with each product.Please note that balloon diameters may vary within manufacturing tolerances.All inflations should be viewed under fluoroscopy.The sleek® otw balloons reach their nominal diameter at 6 atm (608 kpa).Warnings: ¿ do not exceed the rated burst pressure.A syringe with pressure gauge is recommended to monitor pressure.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.¿ use a 20 ml or larger syringe for inflation.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.

• Brand Name: SLEEK OTW PTA DILATATION CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8218396
• Report Number: 9616666-2018-00183
• Device Sequence Number: 11190157
• Product Code: DQY
• UDI-Device Identifier: 00801741133534
• UDI-Public: (01)00801741133534
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K102035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: 426-1508X
• Device Catalogue Number: 426-1508X
• Device Lot Number: CMBN0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1