MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device will be returned.Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported to cook by another manufacturer, a performer introducer was used during placement of another manufacturer's pulmonary artery pressure monitoring device.The intended procedure was completed without incident and the patient completed two hours of flat bedrest postoperatively.No lines remained in the access site.Upon standing for the first time after the procedure, a pop was heard and the groin incision site began to bleed.Manual pressure was held for twenty minutes and a compression device was used at 80mmhg for two hours.The patient was kept overnight for observation.The hematoma had resolved the next morning and the patient's vital signs and hemoglobin were reportedly stable.The patient was discharged without incident.There has been no alleged malfunction of the cook performer introducer.Additional information has been requested, but is not available at this time.
Additional Manufacturer Narrative
Additional information: event summary: as reported to cook by another manufacturer, a performer introducer was used during placement of another manufacturer's pulmonary artery pressure monitoring device.The intended procedure was completed without incident and the patient completed two hours of flat bedrest postoperatively.No lines remained in the access site.Upon standing for the first time after the procedure, a pop was heard, and the groin incision site began to bleed.Manual pressure was held for twenty minutes and a compression device was used at 80mmhg for two hours.The patient was kept overnight for observation.The hematoma had resolved the next morning and the patient's vital signs and hemoglobin were reportedly stable.The patient was discharged without incident.There has been no alleged malfunction of the cook performer introducer.Investigation - evaluation.A document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, documentation, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.At this time there is no alleged device malfunction and thus a representative device from the lot will not be examined.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: the complaint device is packaged with instructions for use (ifu) t_intro_rev6, which states that the device is ¿intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices¿.Precautions include: ¿this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.¿; ¿when inserting, manipulating or withdrawing a device through an introducer always maintain introducer position.The complaint was not confirmed.Based on the investigation results, there is evidence to support that the device was manufactured to specification.At this time, there is no alleged device malfunction.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new patient or event information since the last report was submitted.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11101407
• Report Number: 1820334-2020-02399
• Device Sequence Number: 4088858
• Product Code: DYB
• UDI-Device Identifier: 00827002073692
• UDI-Public: (01)00827002073692(17)230602(10)13144296
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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 Expiration Date: 06/02/2023
• Device Model Number: N/A
• Device Catalogue Number: RCF-12.0-38-J
• Device Lot Number: 13144296
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT CARDIOMEMS, FEM STOP; ABBOTT CARDIOMEMS, FEM STOP
• Outcome Attributed to Adverse Event: Hospitalization