MAUDE Adverse Event Report: COVIDIEN POWERCROSS 018; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	AB18W030120150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a powercross pta balloon for the treatment of a moderately calcified, slightly tortuous lesion in the mid popliteal artery.Lesion exhibited 80% stenosis.It was reported that resistance was encountered when advancing the device, but excessive force was not used.Device did not pass through a previously deployed stent.A longitudinal balloon burst is reported at a pressure of 13atms during inflation.All fragments were retrieved and a new balloon was used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: the powercross device was received.No ancillary devices were included.The powercross was inspected and damage to the catheter was observed.The distal end of the catheter showed the catheter was fractured and separated.The distal segment of the catheter was not returned.The fracture face showed the catheter material twisted/stretched.A radial balloon tear was noted approximately 7cm and 9cm from the distal end of the catheter.The proximal end of the balloon was located approximately 16cm from the end of the catheter.No marker bands were identified, the condition the unit was received indicates the inner assembly/tip of the catheter was stretched out and fractured proximal to the marker bands of the unit.The catheter length measured from the fractured tip to the strain relief was approximately 154cm.An accurate account of the actual working length could not be obtained due to the observed damage.Area of the outer assembly stretching was noted from 59-63cm.The balloon showed 2 radial tears and the catheter fractured at the distal end.The distal end which fractured from the remaining portion of the returned catheter was not included in the returned contents.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POWERCROSS 018
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6776192
• Report Number: 2183870-2017-00339
• Device Sequence Number: 187099
• Product Code: LIT
• UDI-Device Identifier: 00821684046654
• UDI-Public: 00821684046654
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: 07/10/2017
• Device Catalogue Number: AB18W030120150
• Device Lot Number: A119418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR