MAUDE Adverse Event Report: AVANOS MEDICAL INC. GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS; DH EF PERC PLACEMENT PRODUCTS

Model Number 98701

Device Problem Break (1069)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 25-jun-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

It was reported an, "expired t-fastener kit [was used] and 2 of these anchors broke." there was no reported injury.Additional information received 11-jun-2020 stated, "three more sutures were placed at a completely separate site just below the initial access; 2 of 3 sutures broke while advancing the dilator.To prevent the 3rd suture from breaking and hence, complete procedure failure, [the physician] opted to overdilate the tract with a 12 mm balloon [balloon dilator], which then easily facilitated the peel-away sheath." the patient had a positron emission tomography (pet) scan the following week which showed a large pneumoperitoneum, which was causing significant pain.

• Brand Name: GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS
• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10201463
• MDR Text Key: 199496488
• Report Number: 9611594-2020-00110
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770987019
• UDI-Public: 00350770987019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080253
• 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
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 98701
• Device Catalogue Number: 109870103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 56