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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
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.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, 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 Key6706187
MDR Text Key79790210
Report Number9612164-2017-00873
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberPCF050300130
Device Lot Number210980922
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/12/2017 Patient Sequence Number: 1
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