MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number ADM07004013P

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual and tactile inspection was performed on the device: three damages were found on the shaft.The biggest was at the beginning of the working length: the shaft was kinked at the end of the strain relief.Two slightly squeezed areas were found on the shaft at 22cm and 70 cm of the working length.Evident traces of blood were found on the device.The balloon was found partially unfolded, but the protection sheath was found on the balloon.The guide wire lumen was flushed and it was possible to insert the 0,035¿¿ guide wire without any resistance.The purging procedure was performed with no issues.In order to verify the correct profile of the balloon, the device was inserted in a 7f cordis introducer sheath.No resistance was felt both during insertion and extraction.The crossing profile was measured at the proximal balloon welding, in the central part and distal part of the balloon.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 Description

Physician attempted to treat a calcified lesion in the left common iliac artery using in.Pact admiral.Left cfha lesion.The calcified lesion was debunked using hawk one device.The in.Pact admiral 7x40 was taken over spider wire to residual of lesion.The balloon was unable to cross lesion fully in order to accurately treat with dcb.Partial lesions was treated.Dcb was removed.Spider was retrieved.The 035 wire was inserted and used as work horse wire.A 5x40 admiral xtreme was opened and inflated in area of lesion in cfa.Another 7x40 in.Pact admiral was opened and treated the distal part of lesion in cfa.The lesion was severely calcified with 75% stenosis and vessel was none tortuous.Physician encountered moderate resistance while advancing the device to target lesion.The device was removed from the package and prepped as per ifu.There was no injury to patient or clinical sequelae reported for this event.When the device was returned to the manufacturing facility it was noted that the shaft of the device was damaged.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5630334
• MDR Text Key: 44375583
• Report Number: 9612164-2016-00430
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2015
• Device Catalogue Number: ADM07004013P
• Device Lot Number: 0007389965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2014
• 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 Age: 71 YR