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

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.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.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usrll rachel lloyd ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11009438
• MDR Text Key: 221519754
• Report Number: 2125050-2020-01275
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2020

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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1