MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	PCU050250130
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: a visual and a tactile inspection was carried out on the device: traces of dry blood were found on the device.The inspection did not report any abnormality on the device.The device was flushed and a 0.018¿ guide wire was successfully advanced from the tip to the hub of the device.During the analysis, negative pressure was applied with a manometric syringe on the balloon: the purging test didn't pass, since bubbles emerged in the water column.Afterwards, the balloon was inflated in order to detect the leak.A pinhole was found on the balloon at 1 cm from the distal end of the balloon.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
During an attempt to treat a moderately calcified, slightly tortuous fibrous lesion in the left sfa using pacific xtreme balloon catheter, it was reported that the balloon burst at 4 atm during balloon inflation.The device passed through a previously deployed stent.Procedure was completed using atherectomy via "pheonix" followed by 5 mm a non-medtronic balloon.A non-medtronic balloon burst in the same attempt prior to this failure.All fragments of the balloon were retrieved.There was no injury to patient or clinical sequelae.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC XTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana, b.c.,mx
• MDR Report Key: 6662700
• Report Number: 9612164-2017-00800
• Device Sequence Number: 16154163
• Product Code: LIT
• UDI-Device Identifier: 08033477035536
• UDI-Public: 08033477035536
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K103464
• 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,Followup
• Report Date (Section B): 05/26/2017

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: 09/30/2019
• Device Catalogue Number: PCU050250130
• Device Lot Number: 212163992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1