MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196501022

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, the surgeon had to interrupt the surgical intervention because one altis got torn.At first the static anchor has been placed, afterwards the dynamic anchor.While adjusting, the blue suture detached from the static anchor.The mesh has been cut from the suture of the dynamic anchor, both anchors remaining in the patient.As no other altis was available, a serag-wiessner product has been implanted.The procedure was prolonged for about 30 minutes.The patient is well.

Manufacturer Narrative

One altis mesh was received for evaluation.Examination of the returned device revealed the static anchor and suture were detached at the mesh-suture joint.A tear at the suture weld was observed on the static anchor side of the mesh.The dynamic anchor assembly was missing and the suture was cut at the suture loop.A large puncture in the body of the mesh was also observed, indicating the mesh was over-tensioned and had to be loosed with an instrument at some point during the procedure.The information received indicated that during the implanting procedure, the static anchor was placed, afterwards the dynamic anchor was placed.While adjusting, the blue suture detached from the static anchor.The mesh was cut from the suture of the dynamic anchor, both anchors remaining in the patient.The information received and the observations are consistent with over-tensioning the mesh, which may have been done inadvertently, or may have been necessary due to misplacement of one, or both, anchors.In either case, quality concludes that the root cause of the event is use error of the device.This complaint was forwarded to the contract manufacturer (cm) for review.The cm reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, and because the device is not available for evaluation, no further corrective action is required at this time.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6123024983
• MDR Report Key: 7124549
• MDR Text Key: 95175278
• Report Number: 2125050-2017-00621
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5196501022
• Device Catalogue Number: 5196501022
• Device Lot Number: 5124750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other