MAUDE Adverse Event Report: ZIPLINE MEDICAL ZIP 24 SURGICAL SKIN CLOSURE DEVICE; TAPE-BASED WOUND CLOSURE

Model Number PS1240

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); No Information (3190)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

See user facility voluntary emdr report number mw5085077.Subcutaneous incision closure was performed using running barbed sutures.Surface closure was completed using surgical staples and the zipseal 24 skin closure convenience kit, which consists of the zip 24 surgical skin closure device (suspect medical device) and the cardinal health topical skin adhesive (concomitant medical product).Determination of root cause was not possible due to lack of information provided by medical staff.[voluntary user facility report mw508577.Pdf].

Event Description

Total hip arthroplasty patient was re-admitted to operating room for re-closure of surgical incision after patient discharge on pod 4.No further details were provided.See voluntary report number mw5085077 generated by user facility.

Manufacturer Narrative

See user facility voluntary emdr report number mw5085077 (attached).Subcutaneous incision closure was performed using running barbed sutures.Surface closure was completed using surgical staples and the zipseal 24 skin closure convenience kit, which consists of the zip 24 surgical skin closure device (suspect medical device) and the cardinal health topical skin adhesive (concomitant medical product).Investigation determined that event was caused by inadequate deep suturing.Data corrections: b5 - removed "no further details were reported." added "facility reported that patient complained of bleeding.A pre-intervention diagnosis of "wound dehiscence right total hip arthroplasty with drainage." was reported by medical staff during follow-up investigation." h6 - updated event problem and evaluation codes h10 - removed "determination of root cause was not possible due to lack of information provided by medical staff." added "investigation determined that event was caused by inadequate deep suturing." - attachment: [voluntary user facility report mw508577.Pdf].

Event Description

Total hip arthroplasty patient was re-admitted to or for re-closure of surgical incision after patient discharge on pod 4.Facility reported that patient complained of bleeding.A pre-intervention diagnosis of "wound dehiscence right total hip arthroplasty with drainage." was reported by medical staff during follow-up investigation.See voluntary report number mw5085077 generated by user facility.

• Brand Name: ZIP 24 SURGICAL SKIN CLOSURE DEVICE
• Type of Device: TAPE-BASED WOUND CLOSURE
• Manufacturer (Section D): ZIPLINE MEDICAL; 747 camden ave.; suite a; campbell CA 95008
• MDR Report Key: 8529979
• MDR Text Key: 142463328
• Report Number: 3009673389-2019-00005
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2021
• Device Model Number: PS1240
• Device Catalogue Number: PS1240
• Device Lot Number: 0000110434
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDINAL HEALTH TOPICAL SKIN ADHESIVE; SURGICAL STAPLES
• Patient Outcome(s): Required Intervention