MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number A35HPV06040040

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure ((b)(6) 2017) the left venous outflow was treated with fortex balloon catheter and an in.Pact admiral balloon catheter.Approximately 4 months post index procedure ((b)(6) 2018), the patient suffered shunt stenosis.The patient was treated with medication and pta of the venous outflow ((b)(6) 2018).The patient is reported to have recovered well.

Manufacturer Narrative

During the index procedure one fortrex standard pta was used with an admiral xtreme, 4 months post index procedure a fortrex balloon and an admiral xtreme used.Update (b)(6) 2018: approximately 6 months post index procedure ((b)(6) 2018), the patient suffered shunt stenosis.This was treated with medication and pta of the venous outflow ((b)(6) 2018).The patient recovered.Update (b)(6) 2018: approximately 9 months post index procedure ((b)(6) 2018), the patient suffered avf shunt stenosis.The patient was treated with medication and target vessel revascularisation using a non-medtronic device ((b)(6) 2018).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Updated information: approximately 11.5 months post index procedure the patient suffered avf shunt stenosis.The patient was treated with medication and target vessel revascularisation using a non-medtronic device on (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Approximately 14 months post index procedure and 10 months post revascularisation procedure, avf shunt stenosis was reported.The patient was treated with medication and revascularization of venous outflow was carried out using a non-mdt pta.Approximately 18 months post index procedure and 14 months post revascularisation procedure the patient suffered avf shunt stenosis and was treated with medication and pta of the venous outflow approximately 21.5 months post index procedure and 16.5 months post revascularisation procedure, the patient suffered avf shunt stenosis and was treated with medication and pta of the venous outflow.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The cec adjudicated the revascularisation as target lesion, clinically driven and related to the device but not related to the procedure or paclitaxel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7338256
• MDR Text Key: 102366586
• Report Number: 2183870-2018-00146
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2020
• Device Catalogue Number: A35HPV06040040
• Device Lot Number: A428756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 75