MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT AV ACCESS; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number AVC06012008P

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

As part of the in.Pact av access study, patient received treatment of a minimally tortuous, non-calcified diffuse lesion in the venous outflow in the left arm with an in.Pact av access device.A non-mdt sheath and a non-mdt inflation device were used.It is reported the index procedure went very smooth, and no resistance was encountered during balloon insertion.Balloon was inflated once with the highest pressure applied 14atm.When the physician attempted to retrieve the dcb catheter, some resistance was experienced which required the physician to pull on the dcb catheter strongly.The dcb balloon catheter became stuck in the sheath while retrieving it.The physician pulled it strongly and finally retrieved the dcb catheter and the sheath all together.The dcb balloon was pulled out of the sheath and it was found that the dcb balloon was crumpled like a ¿squeezebox/folded¿.Following retrieval of the dcb out of the sheath, the physician dilated the dcb to see if there was any balloon deficiencies/damages and it was reported that visually there were no issues.No patient injury reported.Please note that this device in.Pact av access is not marketed in the united states; however, it is similar to the united states marketed device in.Pact admiral.This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

Manufacturer Narrative

Device evaluation summary: the device was returned for analysis.A visual and tactile inspections were performed on the device and no issues were found on the device.The balloon was found unfolded, used and bloodstained.The is returned together with the device.The guide wire lumen was full of hardened blood therefore it was not possible to flush the lumen and also to load the guide wire.In these conditions it was not possible to test the is compatibility.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT AV ACCESS
• 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: 7101621
• MDR Text Key: 94555161
• Report Number: 9612164-2017-01856
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2019
• Device Catalogue Number: AVC06012008P
• Device Lot Number: V07396186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 54