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

Catalog Number PCF050300130

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Physician was busy to do angioplasty in the sfa.He inflated the balloon once, and kept it inflated for 3 minutes.He then wanted to inflate again in the area more codal.The area was very calcified.Upon inflating the balloon, it burst.When physician retracted the balloon, it seemed as if the proximal end of the balloon was ripped off.Physician could not detect any substantial flow inhibition in the sfa or tibial arteries, to indicate that the ripped off balloon was stuck in the vessel.The vessel was moderately tortuous and lesion is severely calcified.The lesion was no pre dilated.The detached balloon was nowhere to be found.Physician did a sonar the next day, but could not detect any foreign object in the arteries.The detached balloon was not removed.Physician is of the opinion that he pressed the detached balloon against the vessel wall with the stent that he put in afterwards.Patient was doing well and sent home after two days of recovery.

• Brand Name: PACIFIC XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6706187
• MDR Text Key: 79790210
• Report Number: 9612164-2017-00873
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: PCF050300130
• Device Lot Number: 210980922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/12/2017
• Date Device Manufactured: 03/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR