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

Catalog Number	AB18W060100150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a powercross balloon to treat a severely calcified and slightly tortuous mid left iliac artery lesion exhibiting 100% occlusion.The device was used with a non-mdt sheath <(>&<)> guidewire.No embolic protection was used.The device was removed from its packaging without issue and inspected with no issues noted.The ifu was followed during the procedure.The device did not pass through a previously deployed stent.It was reported that resistance was encountered when advancing the device and that excessive force was used during delivery of the device.During the initial balloon inflation, using a syringe and contrast/saline mix, a balloon burst occurred.Following this, it was reported that a fragment of the balloon remained in the patient.The patient attended the or where the balloon fragment was removed by common femoral endarterectomy.No further patient injury was reported.

• 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: 7323289
• Report Number: 2183870-2018-00131
• Device Sequence Number: 11164072
• Product Code: LIT
• UDI-Device Identifier: 00821684046883
• UDI-Public: 00821684046883
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2019
• Device Catalogue Number: AB18W060100150
• Device Lot Number: A384661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 77