MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	G48007
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number: k171275.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported via medwatch 3500a, during a pericardiocentesis in (b)(6) 2019, a micropuncture transitionless stiffened cannula access set wire guide separated in the patient's subcutaneous tissue.The (b)(6) year-old male patient had a reported history of morbid obesity, coronary heart disease, hepatic and renal dysfunction including cryptogenic cirrhosis post orthotopic liver transplantation (2011) and end-stage renal disease post living-unrelated renal transplant (2011); gastroparesis requiring gastrojejunostomy in 2011, gastroesophageal reflux disease, hypothyroidism, depression, pancytopenia (first observed in (b)(6) 2019), and 22% myeloblasts on bone marrow biopsy.Reportedly, during "one of the unsuccessful attempts" of passing a micropuncture wire into the pericardial space, the wire became kinked in the subcutaneous tissue (a non-reportable event).Upon removing the needle and wire, less than one centimeter of the wire sheared off into the subcutaneous space.The separated portion was not retrieved, reportedly because it was in the subcutaneous tissue and the patient was morbidly obese.There has been no report that the patient required any additional procedures or experienced any adverse effects due to this event.
Event or Problem Description
Additional information was received (b)(6) 2019 from the initial reporter.Contrary to previous information received, the initial reporter stated that no section of the device remained inside the patient's body.The reported device kink and separation occurred at different locations on the wire.Although the original report stated the procedure was a pericardiocentesis, information provided on (b)(6) 2019 states "replaced with a new picc line".Further clarification regarding this additional information has been requested but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.B5: additional information.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Event summary: as reported via medwatch 3500a, during a pericardiocentesis in (b)(6) 2019, a micropuncture transitionless stiffened cannula access set wire guide separated in the patient's subcutaneous tissue.The 44 year-old male patient had a reported history of morbid obesity, coronary heart disease, hepatic and renal dysfunction including cryptogenic cirrhosis post orthotopic liver transplantation (2011) and end-stage renal disease post living-unrelated renal transplant (2011); gastroparesis requiring gastrojejunostomy in 2011, gastroesophageal reflux disease, hypothyroidism, depression, pancytopenia (first observed in (b)(6) 2019), and 22% myeloblasts on bone marrow biopsy.Reportedly, during "one of the unsuccessful attempts" of passing a micropuncture wire into the pericardial space, the wire became kinked in the subcutaneous tissue (a non-reportable event).Upon removing the needle and wire, less than one centimeter of the wire sheared off into the subcutaneous space.The separated portion was not retrieved, reportedly because it was in the subcutaneous tissue and the patient was morbidly obese.There has been no report that the patient required any additional procedures or experienced any adverse effects due to this event.Additional information was received 04nov2019 from the initial reporter.Contrary to previous information received, the initial reporter stated that no section of the device remained inside the patient's body.The reported device kink and separation occurred at different locations on the wire.Although the original report stated the procedure was a pericardiocentesis, information provided on 04nov2019 states "replaced with a new picc line".Further clarification regarding this additional information has been requested but is not available at this time.Investigation ¿ evaluation: reviews of the complaint history, device history record, documentation, manufacturer¿s instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that a definitive conclusion could not be confirmed; however, a likely cause for the event is related to the patient¿s anatomy.The separated portion was not retrieved, reportedly because it was in the subcutaneous tissue and the patient was morbidly obese.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9176866
• Report Number: 1820334-2019-02563
• Device Sequence Number: 16798010
• Product Code: DYB
• UDI-Device Identifier: 00827002480070
• UDI-Public: (01)00827002480070(17)220531(10)9775079
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: G48007
• Device Catalogue Number: MPIS-501-10.0-SC-NT-SST
• Device Lot Number: 9775079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 04/08/2020
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/04/2019; 04/15/2020
• 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
• Patient Age: 44 YR