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

Catalog Number	PCP060120130
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use a pacific plus during procedure for treatment of the mid common iliac artery.The fibrous lesion exhibited little tortuosity, no calcification with 70% stenosis.Artery diameter is reported to be 7mm with a lesion length of 120mm.It is reported that the patient had a tumor that compressed the artery.The balloon was inflated using a non-medtronic inflation device, and 50/50 contrast/saline was used.There was no damage to the packaging.There were no issues noted when removing the device from the hoop/tray.The device was prepped with no issues identified.It is reported that balloon inflation difficulties occurred.The event was not observed during balloon inflation.It is reported that 2nd inflation was unsuccessful.When negative was pulled on the device, blood was present in the inflator.The physician removed the balloon and observed the balloon was no longer on the catheter.The physician imaged the anatomy and found the balloon sleeve inside the sheath.The physician was able to remove the sheath and maintain wire access to remove the balloon piece.It is reported that 4 atm was applied when it was determined that there was inflation difficulties.Removal difficulties and difficulty removing the balloon following balloon inflation was reported.The device passed through a previously deployed stent.No resistance was encountered when advancing the device and excessive force was not used.The physician used a 035 balloon to post dilate the stent.
Additional Manufacturer Narrative
Evaluation summary: the catheter was full of hardened blood.The catheter returned broken in 2 parts: the balloon with tip, a part of guidewire and the distal marked still crimped on it; the proximal part of the catheter with hub and shaft, the proximal marker still crimped on the guidewire tube.The detachment between balloon and shaft happened at the proximal balloon welding.The balloon was unfolded, dirty of blood and bounced 1 cm from the tip.The guidewire tube underneath the balloon was highly stretched and broken before the distal marker.No other tests were performed due to the device condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC PLUS US
• 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: 6742377
• Report Number: 9612164-2017-00938
• Device Sequence Number: 19144221
• Product Code: LIT
• UDI-Device Identifier: 08033477054902
• UDI-Public: 08033477054902
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123358
• 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): 08/23/2017

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: 06/30/2019
• Device Catalogue Number: PCP060120130
• Device Lot Number: 211589989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 47