MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER* CATHETER 5 IN (12.5 CM); CATHETERS

Model Number PM020-A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 20-feb-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 125 ml, flow rate: unknown, procedure: vertical laparotomy, cathplace: rectus sheath.It was reported a silver soaker catheter snapped when the clinician was trying to remove it after 3-days in use.Initially, two catheters were positioned in the rectus sheath, one at each side, under direct vision by the surgeon at the end of a vertical laparotomy.After 3-days, when it was decided the catheters should come out, one of the catheters was removed easily, but the other one was stuck.The usual advised remedies were applied (i,e.Warm packs, etc.) but still it would not loosen.While pulling, eventually the catheter broke leaving a 12cm segment of the silver-soaker catheter inside the patient.The patient was not well due to underlying health issues, other pathologies and high anaesthetic risk.Taking the patient back to the surgical theatre to have another laparotomy to remove the catheter was judged less than ideal.During discussions the surgeons were contemplating leaving the broken catheter segment inside the patient's body.Additional information received 07-feb-2019 stated according to the surgeon it was an uneventful placement of the catheter, under direct vision in the posterior rectus sheath.Judged by the surgeon as far enough lateral from suturing.There was another similar catheter inserted in the other side, which was removed uneventfully, both 12.5 cm silver-soaker.The catheters were in use for just under 3-days during removal the catheter was very stretched where it snapped.The patient remains an in-patient, and is now also suffering clostridium difficile (cd) diarrhea.The fact that the patient remains an in-patient is probably unrelated to the fact that part of the catheter is still in-place, but rather due to the several other pathologies and problems related to the patient's health.No additional information was provided.

Manufacturer Narrative

The actual complaint product was returned for evaluation.All information reasonably known as of (b)(6) 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(6).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

Manufacturer Narrative

One broken catheter sample was received.The device was evaluated.The severed end was examined under magnification.The end was jagged.The catheter exhibited stretching/narrowing proximal to the separation.There was dried white matter inside the catheter.The root cause was not identified.All information reasonably known as of 29-apr-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8361343
• MDR Text Key: 139602209
• Report Number: 2026095-2019-00032
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 30680651135354
• UDI-Public: 30680651135354
• Combination Product (y/n): N
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM020-A
• Device Catalogue Number: 101353503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 03/06/2019; 04/09/2019
• Supplement Dates FDA Received: 03/21/2019; 04/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 20