MAUDE Adverse Event Report: RAYNHAM 12.5 FR (4.2 MM) (.166 IN.) PEEL-AWAY CATHETER INTRODUCER; CATHETER PASSERS AND INTRODUCERS

Model Number	831325
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Apnea (1720); Bradycardia (1751)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported: "patient went apneic and desated.¿ppv¿ started and then heart rate (hr) dropped below 60 and chest compressions started.Neonatal team called to room.After ventriculoperitoneal (vp) shunt surgery patient developed pneumoperitoneum.The patient was taken back to operating room (or) where the vp shunt was found to be through anterior and posterior wall of stomach at lesser curvature, and through transverse colonic mesentery.The shunt was removed from the stomach and both defects were over sewn.The patient had returned from the or approximately 30 minutes prior to event.Transitioned to nc (nasal cannula), then went apneic.Codman split sheath trocar went through anterior and posterior walls of the stomach.The catheter introducer used was the smaller size 12.5.".
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The catheter introducer (id 831825) was not returned for evaluation as the product was discarded ; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: 12.5 FR (4.2 MM) (.166 IN.) PEEL-AWAY CATHETER INTRODUCER
• Common Device Name: CATHETER PASSERS AND INTRODUCERS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15431475
• Report Number: 3014334038-2022-00205
• Device Sequence Number: 20485537
• Product Code: GYK
• UDI-Device Identifier: 10381780521402
• UDI-Public: 10381780521402
• Combination Product (Y/N): N
• PMA/510(K) Number: K883607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: 831325
• Device Catalogue Number: 831325
• Device Lot Number: 5955073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 05/19/2023
• Date Device Manufactured: 11/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 7 DA
• Patient Sex: Female