MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, though not verified, the territory manager (tm) reported that she was not present at this case.The circulator, called the tm at the end of the day and reported that during the physician¿s second case of the day, the suture tore off of the mesh, and the tip broke off of the introducer.The tm was not able to get any more details from the circulator and asked to speak to a scrub tech who often works these cases with the physician.The scrub tech said that the physician implanted the first static side without issue, but he tried many times to implant the dynamic side, but it would not anchor/hold to the patient¿s membrane.In trying multiple times, the suture finally tore away from the mesh.They grabbed another altis, and the same thing happened again: the static side was implanted without issue, but the static side would not hold.The scrub tech said that the physician tried to bend the introducer (outside of the patient) to see if he could get a better angle, and that is when he broke off the tip.The physician ended up using prolene to suture the second side of the mesh to the patient¿s tissue.There was no delay as they had another altis nearby.The scrub tech said that she and the physician believe that the issues they encountered during this case were because of the patient¿s anatomy.The scrub tech said that the physician said the patient¿s tissue/membrane was very thin and weak, and that is why he thinks the dynamic anchor wouldn¿t hold.Patient outcome: the physician implanted a second altis sling, and the patient was not harmed.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Manufacturer Narrative

Two introducers were received for evaluation.Examination of both introducers confirmed the tip of the right introducer to be detached.Microscopic examination of the detachment surfaces revealed them to be rough and irregular.No functional abnormalities were noted with the left introducer.Based on the information received the physician tried to bend the introducer tip to a different angle to try and successfully implant the anchor when the tip broke off outside the patient.The physician also noted that the patient¿s tissue/membrane was very thin and weak and may have been a contributing factor as to why the anchor would not hold.Examination of the returned introducer confirmed the separation of the tip.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11009409
• MDR Text Key: 221777489
• Report Number: 2125050-2020-01276
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 7261727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Date Manufacturer Received: 11/17/2020
• Patient Sequence Number: 1