MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION SINGLE USE GUIDWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Per literature review: effectiveness of early endoscopic ultrasound-guided drainage for postoperative fluid collection" (surgical endoscopy (2022) 36 135-142).The study assessed the efficacy and safety of the early drainage (< 4 weeks) of postoperative abdominal fluid collections (pafcs) via endoscopic ultrasound (eus)-guided drainage guidance.A total of 48 patients who had undergone eus-guided pafc drainage within 4 weeks of pancreatobiliary surgery were enrolled.The indications of procedure included abdominal pain (27), fever (18), leukocytosis (2), and increased size of pafc during external tube drainage (1).Technical success was achieved in all cases, and the clinical success rate was (b)(4).Four patients underwent secondary procedures.Adverse events occurred in two cases that were developed intracystic bleeding and were successfully resolved by arterial coil embolization.It is unknown if there is a causal link between the adverse events and the product.The patient impact was harmed but non-serious.

Manufacturer Narrative

Establishment name: (b)(6).The actual sample was not returned and no information to identify the involved product code/lot was available, review of manufacturing record or product-release judgement records could not be performed.Regarding the representative product code (ol-xa25455), we received three similar reports in the past five years (may 2017 - may 2022).All three reports are from the published literature: the first case reported acute pancreatitis and infection after ercp, the second case reported an incidental disease after eus-hgs, and the third case reported acute cholecystitis after sems implantation.The circumstances of each case were different from those of this case.In all three cases, the causal relationship between the products and the events was unknown, as the actual samples were not available and the involved lot numbers were unknown.This product has undergone iso10993 compliant biological safety evaluation (cytotoxicity, skin sensitization, intradermal reaction, acute toxicity, pyrogen, and hemolysis) at the product design stage.Ashitaka conducts the following safety test regularly: (i) indicator bacteria test, (ii) endotoxin test, (iii) extraction test, (iv) residual eo, ech test.The literature studies and evaluates the effectiveness and safety of early (within four weeks) eus guided drainage for pafcs.As it does not mention any defects of the product itself or adverse events associated with the product, no causal link between this complaint and the product was confirmed.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Manufacturer Narrative

A1: patient identifier - unknown, literature review.A2: age & date of birth - unknown, literature review.A3: patient sex - unknown, literature review.A4: weight - unknown, literature review.A5: ethnicity - unknown, literature review.A6: race - unknown, literature review.B3: date of event: unknown, literature review.D4: lot number - unknown, literature review.D4: expiration date: unknown due to unknown lot number.D4: udi: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: initial reporter name - unknown, literature review.E1: establishment name - (b)(6) center (b)(6) of medicine.E2: health professional- unknown, literature review.E3: occupation- unknown, literature review.G4: manufacture date - unknown due to unknown lot number.This report is being submitted as follow up no.1 to report the initial information for this complaint.The initial report was submitted june 9, 2022, and came back with a failed ack stating that "thu jun 09 22:45:07 edt 2022 1 0 form 3500a - icsr r2 failed 9681834-2022-00108 report identifier".The actual sample was not returned and no information to identify the involved product code/lot was available, review of manufacturing record or product-release judgement records could not be performed.Regarding the representative product code (ol-xa25455), we received three similar reports in the past five years (may 2017 - may 2022).All three reports are from the published literature: the first case reported acute pancreatitis and infection after ercp, the second case reported an incidental disease after eus-hgs, and the third case reported acute cholecystitis after sems implantation.The circumstances of each case were different from those of this case.In all three cases, the causal relationship between the products and the events was unknown, as the actual samples were not available and the involved lot numbers were unknown.This product has undergone iso10993 compliant biological safety evaluation (cytotoxicity, skin sensitization, intradermal reaction, acute toxicity, pyrogen, and hemolysis) at the product design stage.Ashitaka conducts the following safety test regularly: (i) indicator bacteria test, (ii) endotoxin test, (iii) extraction test, (iv) residual eo, ech test.The literature studies and evaluates the effectiveness and safety of early (within four weeks) eus guided drainage for pafcs.As it does not mention any defects of the product itself or adverse events associated with the product, no causal link between this complaint and the product was confirmed.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

Per literature review: effectiveness of early endoscopic ultrasound-guided drainage for postoperative fluid collection" (surgical endoscopy (2022) 36 135-142).The study assessed the efficacy and safety of the early drainage (< 4 weeks) of postoperative abdominal fluid collections (pafcs) via endoscopic ultrasound (eus)-guided drainage guidance.A total of (b)(4) patients who had undergone eus-guided pafc drainage within 4 weeks of pancreatobiliary surgery were enrolled.The indications of procedure included abdominal pain (27), fever (18), leukocytosis (2), and increased size of pafc during external tube drainage (1).Technical success was achieved in all cases, and the clinical success rate was (b)(4).(b)(4) patients underwent secondary procedures.Adverse events occurred in two cases that were developed intracystic bleeding and were successfully resolved by arterial coil embolization.It is unknown if there is a causal link between the adverse events and the product.The patient impact was harmed but non-serious.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14648416
• MDR Text Key: 294904149
• Report Number: 9681834-2022-00108
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EUSN-19-T(COOK ENDOSCOPY); EUSN-19-T(COOK ENDOSCOPY); GF-UCT260 OLYMPUS; GF-UCT260 OLYMPUS; HURRICANE (BOSTON SCIENTIFIC); HURRICANE (BOSTON SCIENTIFIC); JAGWIRE(BOSTON SCIENTIFIC); JAGWIRE(BOSTON SCIENTIFIC); M-FCSEMSB ONA-SOO STENT (STANDARD SCI TECH); M-FCSEMSB ONA-SOO STENT (STANDARD SCI TECH); MICROTOME (BOSTON SCIENTIFIC); MICROTOME (BOSTON SCIENTIFIC)
• Patient Outcome(s): Other