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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 PCF050150130
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2019
Event Type  malfunction  
Manufacturer Narrative
Additional information: the pacific xtreme balloon was used for post dilation of the right superficial femoral artery during a procedure to implant an se stent. A non-medtronic 5fr sheath and a non-medtronic guidewire were used. Ifu was followed. The balloon was safely removed from the patient. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was using pacific xtreme balloon catheter, it was reported that when balloon was inflated in vivo to the nominal pressure a pinch was observed in the proximal third of the balloon. The pinch was persistent on the same location in the balloon both in other positions in vivo and in vitro. The procedure was completed using an se stent. There was no patient injury reported.
 
Manufacturer Narrative
Image review: two photographic images of cine images of the balloon catheter inflated within the targeted vessel anatomy were received. Both images show a section of the balloon not fully inflated at a focalized point, (e. G. Candy wrapped). The balloon is being used to post-dilate a stent. The first image the balloon catheter is being used to post-dilate the proximal end of the stent. The second image the balloon catheter is being used to post-dilate the distal end of the stent. The focalized balloon twist (e. G. ¿candy wrapper¿ is located approximately in the same position in both inflations). Product analysis: the pacific xtreme pta balloon catheter was received by medtronic for evaluation, loosely coiled within its opened labelled pouch. No ancillary devices were received for analysis. The pacific xtreme catheter was received with the balloon in post-inflation profile, (e. G. Not tightly wrapped or winged). The inner guidewire lumen exhibited undulation of being stretched. The balloon chamber exhibited twisting witness marks. A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed; a steady stream of fluid was observed exiting the distal end of the catheter. A 0. 018¿ guidewire was loaded through the distal tip and navigated out the proximal hub with ease. The lot number information printed on the y-manifold is consistent with the pouch label and reported event. A 10cc water filled syringe was attached to the inflation lumen luer lock. A vacuum was able to be pulled and maintained; indicating no leaks in the inflation pathway or balloon chamber. The syringe was lightly pressurized, and the twisting witness marks were still visible in the balloon chamber material. A 20cc water filled syringe with manometer was attached to the inflation lumen luer lock and pressurized to nominal pressure of 6 atm; no leaks noted but twisting witness marks are still present in the balloon chamber material. The 20cc syringe with manometer was pressurized to rated burst pressure, (14 atm); no leaks noted but twisting witness marks are still present in the balloon chamber material. The balloon catheter was fully deflated, and the guidewire was removed; twisting witness marks remained in the balloon chamber material. If information is provided in the future, a supplemental report will be issued.
 
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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 Key9400818
MDR Text Key170792534
Report Number9612164-2019-04984
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIS
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,Followup,Followup
Report Date 03/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/21/2022
Device Catalogue NumberPCF050150130
Device Lot Number217356014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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