MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX; CLIP, VASCULAR

Model Number A1603

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.

Event Description

Procedure performed: coronary artery bypass grafting (cabg)."according to the or tech: this happened approximately six times before.The failure consisted of the clamp being no-occlusive (not clamping completely).This caused hemorrhage into the thoracic space.The spring/ slide mechanism is what appeared to be the failure point." additional information was received from msn, rn, clinical risk manager at [name], via e-mail on november 7th, 2019: "in each case, the clamps were checked before use, and determined to be fine, but still failed during application to the ima.There were multiple failure dates (up to six), which we are unable to track down.All cases were coronary bypass grafting (our only use at drmc) and failed while clamping the internal mammary artery while on bypass.(this is why patients didn't exsanguinate).Shed blood was returned to the bypass circuit after blood loss was discovered.This was the same situation for all failure cases.Unable to determine permanent injury.Unable to determine any lot numbers except the one indicated in the complaint, which was packaged to return to applied." additional information was received from msn, rn, clinical risk manager at [name], via e-mail on november 13th, 2019: "per our or team:" "it is impossible to accurately quantify blood loss in those cases, since shed blood during open heart surgery goes right back into the patients circulation via the heart-lung machine.This also explains how the blood loss was dealt with.Yes, standard surgical procedure's resolved the issue." intervention: "shed blood was returned to the bypass circuit after blood loss was discovered." patient status: "unable to determine permanent injury".

Manufacturer Narrative

The event unit was returned to applied medical for evaluation along with a non-incident unit.Testing was performed on the units; however, engineering was unable to confirm that the scissors were hard to handle as the units were able to actuate smoothly and cut without any issues.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Difficulty in handling scissors is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.The event was reported based on the event description of rough actuation and prior to evaluating the returned unit.

Event Description

Procedure performed: coronary artery bypass grafting (cabg) "according to the or tech: this happened approximately six times before.The failure consisted of the clamp being no-occlusive (not clamping completely).This caused hemorrhage into the thoracic space.The spring/slide mechanism is what appeared to be the failure point." additional information was received from ,msn, rn, clinical risk manager, via e-mail on november 7th, 2019: "in each case, the clamps were checked before use, and determined to be fine, but still failed during application to the ima.There were multiple failure dates (up to six), which we are unable to track down.All cases were coronary bypass grafting (our only use at drmc) and failed while clamping the internal mammary artery while on bypass.(this is why patients didn¿t exsanguinate).Shed blood was returned to the bypass circuit after blood loss was discovered.This was the same situation for all failure cases.Unable to determine permanent injury.Unable to determine any lot numbers except the one indicated in the complaint, which was packaged to return to applied." additional information was received from , msn, rn, clinical risk manager, via e-mail on november 13th, 2019: "per our or team:" "it is impossible to accurately quantify blood loss in those cases, since shed blood during open heart surgery goes right back into the patients circulation via the heart-lung machine.This also explains how the blood loss was dealt with.Yes, standard surgical procedure¿s resolved the issue." additional information received via email on 23dec2019, clinical risk manager: "i heard back from the or: in regards to your inquiry: "as we continue to investigate the six additional cers of non-occluding clips, we are looking for a timeline of when these occurrences took place.For example, did these events occur over the last 6 months, 3-4 months, or 1-2 months?" per the or: "it was happening for approximately 30 days prior to report.I don¿t have exact dates and times." and re: "we are also wondering if they can confirm whether a clip applicator or other devices were used to apply the clips in these cases?" per the or: "fingers." intervention: "shed blood returned to the bypass circuit after blood loss was discovered." patient status: unable to determine permanent injury.

• Brand Name: A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX
• Type of Device: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9330555
• MDR Text Key: 177765247
• Report Number: 2027111-2019-00634
• Device Sequence Number: 1
• Product Code: DSS
• Combination Product (y/n): N
• PMA/PMN Number: K883909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A1603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1