MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW FLEXTIP PLUS(R) EPIDURAL CATHETERIZATION KIT; CATHETER, CONDUCTION, ANESTHETIC

Model Number	IPN045606
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per anesthesiologist, attempt at l4/5, os at multiple angles before lor (loss of resistance), unable to thread catheter smoothly.Considered thin epidural space at that level not suitable for epidural catheter.Attempt at l3/4, os at multiple angles before lor, again unable to thread catheter smoothly.Attempt at l5/s1, lor at 7 cm, epidural catheter advanced smoothly into epidural space.Resistance when retrieving needle, stopped pulling immediately on needle, and decided to pull needle and epidural catheter together.When needle removed, saw exposed inner wire from catheter.Pulled all of wire out.Compared pulled catheter to new catheter and noted approximately 5 cm of catheter presumed to remain in epidural space.Patient denied paraesthesias or neurological symptoms during all the attempts and after removal of catheter.Another catheter was placed without complication.Patient underwent cesarean section without complication.Neurosurgeon consulted.Ct scan order of the lumbar spine to determine the position of the retained catheter fragment.Ct scan confirmed presence of retained catheter at the l4-5 level, appeared to be epidural, left side extending into the proximal portion of the left l4-5 foramen.Laminotomy performed on [date redacted]- retained catheter fragment was successfully retrieved.Patient did well post operatively and was discharged [date redacted].
Event or Problem Description
Per anesthesiologist, attempt at l4/5, os at multiple angles before lor (loss of resistance), unable to thread catheter smoothly.Considered thin epidural space at that level not suitable for epidural catheter.Attempt at l3/4, os at multiple angles before lor, again unable to thread catheter smoothly.Attempt at l5/s1, lor at 7 cm, epidural catheter advanced smoothly into epidural space.Resistance when retrieving needle, stopped pulling immediately on needle, and decided to pull needle and epidural catheter together.When needle removed, saw exposed inner wire from catheter.Pulled all of wire out.Compared pulled catheter to new catheter and noted approximately 5 cm of catheter presumed to remain in epidural space.Patient denied paraesthesias or neurological symptoms during all the attempts and after removal of catheter.Another catheter was placed without complication.Patient underwent cesarean section without complication.Neurosurgeon consulted.Ct scan order of the lumbar spine to determine the position of the retained catheter fragment.Ct scan confirmed presence of retained catheter at the l4-5 level, appeared to be epidural, left side extending into the proximal portion of the left l4-5 foramen.Laminotomy performed on [date redacted]- retained catheter fragment was successfully retrieved.Patient did well post operatively and was discharged [date redacted].

• Brand Name: ARROW FLEXTIP PLUS(R) EPIDURAL CATHETERIZATION KIT
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 10471035
• Report Number: 10471035
• Device Sequence Number: 2345074
• Product Code: BSO
• UDI-Device Identifier: 40801902005128
• UDI-Public: (01)40801902005128(17)210930(10)23F20D0276
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020
• Report Date (Section F): 08/20/2020

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
• Operator of Device: Health Professional
• Device Model Number: IPN045606
• Device Catalogue Number: AK-05501
• Device Lot Number: 23F20D0276
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Weight: 97
• Date Report Sent to FDA: 08/20/2020