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

Catalog Number	PCU070200130
Medical Device Problem Code	Material Distortion (2977)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the device was returned for analysis in the original box.The data on the luer was consistent with lot number indicated in the product complaint form.A visual and tactile inspections were performed.No damages has been noted on the shaft.The balloon was used.A twisted area was noted on the balloon.The guide wire lumen was flushed and it was possible to insert the 0.018¿¿ guide wire without any resistance.The purging procedure was performed with no issues.The balloon was inflated at 1 bar and its profile resulted deformed in the point of twisting.The deformation disappeared increasing the inflating pressure over 10 bar.It was possible to note a deformation point on the guide wire tube just below the wrinkled area, identified as point of twist.No further issues found.Cine image review: an angio image was provided confirming the claimed issue and supporting the result seen through product analysis.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
Physician attempted to treat patient at the left, distal superficial femoral artery using a pacific xtreme balloon.Target lesion was calcified and fibrous with little tortuosity, moderate calcification and 75% stenosis.Artery diameter was 7 mm and lesion length was 300 mm.It is reported that when inflating the balloon to 4 atm using an inflation device and fluid (1:1, hep saline: contrast) a balloon twist occurred.The balloon was used during 3 separate inflations, with the twist being observed in every inflation.
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; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 6329170
• Report Number: 9612164-2017-00174
• Device Sequence Number: 674020
• Product Code: LIT
• UDI-Device Identifier: 08033477035383
• UDI-Public: 08033477035383
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

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: PCU070200130
• Device Lot Number: 212212605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/14/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR